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RECRUITING
NCT06788990
PHASE2/PHASE3

FORTIFI-HN01: A Study of Ficerafusp Alfa (BCA101) or Placebo in Combination With Pembrolizumab in First-Line PD-L1-pos, R or M HNSCC

Sponsor: Bicara Therapeutics

View on ClinicalTrials.gov

Summary

Ficerafusp alfa is directed against two targets, Epidermal Growth Factor Receptor (EGFR) and Transforming Growth Factor beta (TGF-β). This study intends to evaluate the safety and efficacy of ficerafusp alfa in combination with pembrolizumab versus placebo with pembrolizumab in 1L PD-L1-positive, recurrent or metastatic Head and Neck Squamous Cell Carcinoma (HNSCC).

Official title: A Multicenter, Randomized, Double-blind, Phase 2/3 Study of Ficerafusp Alfa (BCA101) or Placebo in Combination With Pembrolizumab for First-Line Treatment of PD-L1-positive, Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

650

Start Date

2025-01-28

Completion Date

2029-07

Last Updated

2026-10-29

Healthy Volunteers

No

Interventions

DRUG

Ficerafusp alfa

Investigational

DRUG

Pembrolizumab (KEYTRUDA®)

Immunotherapy agent used in combination with investigational agent

DRUG

Placebo

Placebo Control

Locations (231)

University of Alabama Hospital (Site # 0137)

Birmingham, Alabama, United States

Mayo Clinic Hospital (Site #0147)

Phoenix, Arizona, United States

UC San Diego Moores Cancer Center (Site #0107)

La Jolla, California, United States

UCLA Department of Medicine - Hematology/Oncology (Site #0106)

Los Angeles, California, United States

UC Davis (Site#0144)

Sacramento, California, United States

University of California San Francisco (Site #0130)

San Francisco, California, United States

Stanford Cancer Institute (Site #0150)

Stanford, California, United States

Rocky Mountain Cancer Centers, LLP (Site #0122)

Aurora, Colorado, United States

Rocky Mountain Regional VAMC (Site #0124)

Aurora, Colorado, United States

University of Colorado Cancer Center (UCCC) - Anschutz Medical Campus (Site#0121)

Aurora, Colorado, United States

ChristianaCare Helen F. Graham Cancer Center and Research Institute (Site # 127)

Newark, Delaware, United States

Mayo Clinic Florida (Site #0148)

Jacksonville, Florida, United States

Cancer Care Centers of Brevard (Site #0136)

Palm Bay, Florida, United States

Moffit Cancer Center (Site #0105)

Tampa, Florida, United States

Captain James A Lovell Federal Health Care Center-VA North Chicago (Site # 133)

Chicago, Illinois, United States

University of Iowa Hospitals & Clinics (Site#0140)

Iowa City, Iowa, United States

University of Kansas Medical Center Research Institute, Inc. (Site #0149)

Westwood, Kansas, United States

University of Kentucky, Markey Cancer Center (Site # 109)

Lexington, Kentucky, United States

Norton Cancer Institute (Site#0111)

Louisville, Kentucky, United States

The University of Louisville, James Graham Brown Cancer Center (Site#0115)

Louisville, Kentucky, United States

University of Maryland Medical Group (Site #0112)

Baltimore, Maryland, United States

Massachusetts General Hospital (Site #0131)

Boston, Massachusetts, United States

Dana-Farber Cancer Institute (Site#0101)

Boston, Massachusetts, United States

University of Michigan (Site # 161)

Ann Arbor, Michigan, United States

Site #0156

Maplewood, Minnesota, United States

Mayo Clinic Cancer Center - Rochester (Site #0146)

Rochester, Minnesota, United States

Washington University School of Medicine (Site #0114)

St Louis, Missouri, United States

Hackensack Meridian Health (Site # 119)

Hackensack, New Jersey, United States

Rutgers- Cancer Institute (Site #0145)

Newark, New Jersey, United States

Mount Sinai (Site #0155)

New York, New York, United States

Memorial Sloan Kettering Cancer Center (Site#0142)

New York, New York, United States

Duke University Health System (Site#0118)

Durham, North Carolina, United States

Mercy Hospital (Site#0154)

Canton, Ohio, United States

University of Cincinnati Cancer Institute (Site#0117)

Cincinnati, Ohio, United States

University Hospitals Seidman Cancer Center (Site #0151)

Cleveland, Ohio, United States

Cleveland Clinic (Site #0108)

Cleveland, Ohio, United States

Providence Portland Medical Center (Site #0113)

Portland, Oregon, United States

UPMC Hillman Cancer Center (Site #0103)

Pittsburgh, Pennsylvania, United States

VA Pittsburgh Healthcare System (Site #0123)

Pittsburgh, Pennsylvania, United States

Lifespan Cancer Institute (Site #0132)

Providence, Rhode Island, United States

Medical University of South Carolina (MUSC) (Site#0104)

Charleston, South Carolina, United States

SCRI-Oncology Partners (Site#0126)

Nashville, Tennessee, United States

Vanderbilt-Ingram Cancer Center (Site #0116)

Nashville, Tennessee, United States

MD Anderson Cancer Center (Site#0102)

Houston, Texas, United States

SCRI- Texas Oncology- Central South (Site #0152)

Waco, Texas, United States

University of Virginia (Site#0134)

Charlottesville, Virginia, United States

Virginia Commonwealth University (VCU) Massey Cancer Center (Site #0129)

Richmond, Virginia, United States

Richmond Department of Veterans Affairs (Site #0138)

Richmond, Virginia, United States

Swedish Cancer Institute - North Campus Edmonds (Site # 0160)

Edmonds, Washington, United States

Swedish Cancer Institute (Site # 0159)

Seattle, Washington, United States

University of Washington - Seattle Cancer Care Alliance (Site #0125)

Seattle, Washington, United States

Northwest Cancer Specialists, PC (Site#0120)

Vancouver, Washington, United States

William S. Middleton Memorial Veteran's Hospital (Site #0141)

Madison, Wisconsin, United States

University of Wisconsin Hospital and Clinics (Site #0157)

Madison, Wisconsin, United States

Advocate Aurora Research Institute (Site # 0153)

Milwaukee, Wisconsin, United States

CEMIC (Site # 2301)

Buenos Aires, Argentina

ICM Center (Site # 2306)

Buenos Aires, Argentina

Hospital Universitario Austral (Site # 2303)

Pilar, Argentina

Sanatorio de la Mujer (Site # 2305)

Rosario, Argentina

Hospital Provincial del Centenario (Site # 2302)

Santa Fe, Argentina

Chris O'Brien Lifehouse (Site#0302)

Camperdown, New South Wales, Australia

Nepean Hospital (Site #0306)

Kingswood, New South Wales, Australia

Calvary Mater Newcastle (Site#0304)

Waratah, New South Wales, Australia

Gold Coast University Hospital (Site #0305)

Southport, Queensland, Australia

John Flynn Private Hospital (Site#0307)

Tugun, Queensland, Australia

Austin Health (Site #0303)

Heidelberg, Victoria, Australia

Peter Macallum Cancer Centre (Site#0301)

North Melbourne, Victoria, Australia

Fiona Stanley Hospital (Site#0308)

Murdoch, Western Australia, Australia

Hematology and Medical Oncology, Paracelsus Medical University (Site #1602)

Salzburg, Austria

Medical University Vienna (Site #1601)

Vienna, Austria

AZ St-Jan Brugge Oostende av (Campus Sint-Jan) (Site #1007)

Bruges, Belgium

CHU Ambroise Paré (Site #1005)

Mons, Belgium

CHU UCL Namur, Site Ste. Elisabeth (Site #1002)

Namur, Belgium

CHU UCL Namur, Site Mont-Godinne (Site #1003)

Namur, Belgium

Vitaz (Site #1001)

Sint-Niklaas, Belgium

ZAS Augustinus (Site #1006)

Wilrijk, Belgium

AFECC Hospital Santa Rita de Cassia (Site # 2420)

Santa Cecília, Vitoria ES, Brazil

Hospital de Amor de Barretos - Fundação Pio XII (Site # 2413)

Barretos, Brazil

Centro de Tratamento Oncologico (Site # 2421)

Belém, Brazil

CIONC-Centro Integrado de Oncologia de Curitiba (Site # 2404)

Curitiba, Brazil

Hospital Haroldo Juaçaba - Instituto do Câncer do Ceará (Site # 2414)

Fortaleza, Brazil

Oncosite - Centro de Pesquisa Clinica e Oncologia (Site # 2402)

Ijuí, Brazil

Fundação Doutor Amaral Carvalho (Site # 2411)

Jaú, Brazil

Liga Norte-Rio-Grandense Contra o Câncer (Site # 2422)

Natal, Brazil

Hospital de Clínicas de Passo Fundo (Site # 2419)

Passo Fundo, Brazil

Hospital Nossa Senhora da Conceicao (Site # 2403)

Porto Alegre, Brazil

Grupo Oncoclínicas (Site # 2412)

Rio de Janeiro, Brazil

Hospital Ana Nery (Site # 2415)

Santa Cruz do Sul, Brazil

Oncoclinicas do Brasil Serviços Médicos S.A - Oncocentro BH (Site # 2401)

Santa Lúcia, Brazil

Centro de Oncologia do ABC - Unidade Santo Andre (Site # 2410)

São Caetano do Sul, Brazil

Centro Integrado de Pesquisa do Hospital de Base de São José do Rio Preto/FUNFAR (Site # 2406)

São José do Rio Preto, Brazil

Instituto do Cancer do Estado de Sao Paulo (ICESP) (Site # 2417)

São Paulo, Brazil

A. C. Camargo Cancer Center (Site # 2409)

São Paulo, Brazil

IBCC Núcleo de Pesquisa e Ensino (Site # 2405)

São Paulo, Brazil

Oncoclínicas - SP (Site # 2416)

São Paulo, Brazil

Hospital Santa Marcelina (Site # 2418)

São Paulo, Brazil

BC Cancer - Vancouver (Site #0202)

Vancouver, British Columbia, Canada

Centre Hospitalier de l'Universite de Montreal (CHUM) - Hopital Notre-Dame (Site #0203)

Montreal, Quebec, Canada

Sunnybrook Health Sciences Centre (Site # 0204)

Toronto, Canada

Fakultni Nemocnice Hradec Kralove (FNHK) (Site # 2101)

Hradec Králové, Czechia

And 131 more locations on ClinicalTrials.gov